Terbinafine Hydrochloride TERBINAFINE HYDROCHLORIDE PROFICIENT RX LP FDA Approved Uses • cures most athlete's foot (tinea pedis) • cures most jock itch (tinea cruris) and ringworm (tinea corporis) • relieves itching, burning, cracking and scaling which accompany these conditions
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Route
TOPICAL
Applications
ANDA077511

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient Terbinafine hydrochloride 1%
Inactive Ingredients
Inactive ingredients benzyl alcohol cetyl alcohol cetyl palmitate isopropyl myristate polysorbate 60 purified water sodium hydroxide sorbitan monostearate stearyl alcohol.
Strengths
1 %
Treats Conditions
Uses Cures Most Athlete S Foot Tinea Pedis Cures Most Jock Itch Tinea Cruris And Ringworm Tinea Corporis Relieves Itching Burning Cracking And Scaling Which Accompany These Conditions
Pill Appearance
Color: white

Identifiers & Packaging

Container Type BOX
UPC
0363187111304
UNII
012C11ZU6G
Packaging

PRINCIPAL DISPLAY PANEL - 30 g Carton Cures Most Athlete's Foot Terbinafine Hydrochloride Cream 1% Antifungal Cream Full Prescription Strength NET WT 1 oz (30 g) 63187-111-30

Package Descriptions
  • PRINCIPAL DISPLAY PANEL - 30 g Carton Cures Most Athlete's Foot Terbinafine Hydrochloride Cream 1% Antifungal Cream Full Prescription Strength NET WT 1 oz (30 g) 63187-111-30

Overview

Uses • cures most athlete's foot (tinea pedis) • cures most jock itch (tinea cruris) and ringworm (tinea corporis) • relieves itching, burning, cracking and scaling which accompany these conditions

Indications & Usage

Uses • cures most athlete's foot (tinea pedis) • cures most jock itch (tinea cruris) and ringworm (tinea corporis) • relieves itching, burning, cracking and scaling which accompany these conditions

Dosage & Administration

Directions • adults and children 12 years and older • use the tip of the cap to break the seal and open the tube • wash the affected skin with soap and water and dry completely before applying • for athlete's foot wear well-fitting, ventilated shoes. Change shoes and socks at least once daily. • between the toes only: apply twice a day (morning and night) for 1 week or as directed by a doctor. • on the bottom or sides of the foot: apply twice a day (morning and night) for 2 weeks or as directed by a doctor. • for jock itch and ringworm: apply once a day (morning or night) for 1 week or as directed by a doctor. • wash hands after each use • children under 12 years: ask a doctor 1 week between the toes 2 weeks on the bottom or sides of the foot Figure 1 Figure 2

Warnings & Precautions
Warnings For external use only Do not use • on nails or scalp • in or near the mouth or the eyes • for vaginal yeast infections When using this product do not get into the eyes. If eye contact occurs, rinse thoroughly with water. Stop use and ask a doctor if • too much irritation occurs or gets worse. • side effects occur. You may report side effects to FDA at 1-800-FDA-1088. Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.
Purpose

Purpose Antifungal

Do Not Use

Do not use • on nails or scalp • in or near the mouth or the eyes • for vaginal yeast infections

When Using

When using this product do not get into the eyes. If eye contact occurs, rinse thoroughly with water.

Stop Use & Ask a Doctor

Stop use and ask a doctor if • too much irritation occurs or gets worse. • side effects occur. You may report side effects to FDA at 1-800-FDA-1088.

Keep Out of Reach of Children

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Storage & Handling

Other information • do not use if seal on tube is broken or is not visible • store at controlled room temperature 20°-25°C (68°-77°F) • see carton or tube crimp for lot number and expiration date


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